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Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk

20 Years
40 Years
Not Enrolling
BRCA1 Mutation, Breast Cancer

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Trial Information

Genomic Markers of Breast Cancer Prevention Induced by HCG in Women at High Risk



- Determine whether the genomic profiles of breast epithelial cells of high-breast
cancer-risk women, as defined by their positive BRCA1 status and nulliparous condition,
express a signature indicative of high-risk.


- Determine whether women identified to express a "high-breast cancer-risk" signature
will revert it to a "low-risk" signature after a 90-day treatment with r-hCG, which
should have induced breast differentiation and genomic changes that would serve as
biomarkers indicative of decreased breast cancer risk.

OUTLINE: Patients receive recombinant human chorionic gonadotropin subcutaneously three
times weekly. Treatment continues weekly for 90 days in the absence of unacceptable

Benign breast tissue specimens are collected by core needle biopsy at baseline, day 90, and
day 270. Tissue samples are analyzed by cytopathology for epithelial normality, Ki67
immunohistochemical staining for cell proliferation, cDNA microarray for gene expression,
and serum studies for hormone levels and biomarker determinations.

After completion of study treatment, patients are followed for 24 weeks.

Inclusion Criteria


- Asymptomatic women who have a deleterious mutation on the BRCA1 gene

- Normal, no complaints, no evidence of disease

- Nulliparous, never pregnant (G0P0)

- No previous diagnosis of breast or ovarian cancer

- No known brain metastases

- Hormone receptor status not specified


- ECOG performance status (PS) 0-1 OR Karnofsky PS 90-100%

- Premenopausal with normal menstrual cycles and intact ovaries

- Normal ovarian size report from pelvic ultrasound

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective barrier contraception

- No history of allergic reactions attributed to compounds of similar chemical or
biologic composition to human chorionic gonadotropin preparations or one of its

- No uncontrolled intercurrent illness including any of the following:

- Ovarian enlargement of undetermined origin

- Ovarian cysts > 2 cm

- Microcystic ovaries, which might predispose to the development of ovarian
hyperstimulation syndrome

- History of prior cancer other than non-melanoma skin cancer

- Ongoing or active infection

- Symptomatic congestive heart failure

- Unstable angina pectoris

- Cardiac arrhythmia

- Severe cognitive deficit or psychiatric illness/social situations that would
make her unable to give informed consent or would limit compliance with study


- At least 6 weeks since prior and no concurrent oral contraceptives or
hormone-replacement therapy

- No concurrent tamoxifen for chemoprevention

- No concurrent participation in another chemopreventive trial for breast cancer

- No concurrent medication that could interfere with this study including any of the

- Hormonal contraceptives

- Androgens

- Prednisone

- Thyroid hormones

- Insulin

- No other concurrent investigational agents

- No recent treatment with follicle-stimulating hormone for assisted reproduction

- No HIV-positive patients on concurrent combination antiretroviral therapy

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

Measurement of gene expression in breast epithelial cells obtained for asymptomatic high breast cancer risk nulliparous premenopausal women at baseline, after treatment with r-hCG at 90 days, and at 270 days from baseline

Outcome Time Frame:

90 days and 270 days from baseline

Safety Issue:


Principal Investigator

Jose Russo, MD, FCAP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fox Chase Cancer Center


United States: Food and Drug Administration

Study ID:




Start Date:

July 2008

Completion Date:

Related Keywords:

  • BRCA1 Mutation
  • Breast Cancer
  • breast cancer
  • BRCA1 mutation carrier
  • Breast Neoplasms



Mayo Clinic Cancer Center Rochester, Minnesota  55905
Fox Chase Cancer Center - Philadelphia Philadelphia, Pennsylvania  19111-2497